Regulatory Affairs Manager
by PSA Chemicals and Pharmaceuticals Pvt Ltd in Mumbai, Navi Mumbai
Experience: 3 to 8 yrs. | Opening(s): 3 Posted on: 11 Sep
Job Description
Job responsibilities :
1) Should have leadership qualities and should be able to handle the regulatory team effectively,
2) Should have multi-tasking attributes and should have excellent communication skills to interact with Clients / Customers abroad,
3) Should be able to plan and execute the regulatory affairs activities as per marketing requirements and should be flexible to manage the priorities,
4) Should be well versed with guidelines of ICH and other regulatory agencies,
5) Should be competent with preparation, review and submission of registration dossiers in CTD and ACTD formats,
6) Should be responsible for preparation and timely submission of replies to queries raised by various Regulatory Agencies,
7) Should be responsible for technical review of quality documents on receipt from different locations before inclusion in dossiers and query responses,
8) Should have enough knowledge and experience of liaisoning with FDA for mfg. license, product permissions, CoPP, FSC, WHO-GMP and other technical documents (including notarization and/or attestation from various embassies),
9) Should be responsible for regulatory support for new product developments,
10) Should be responsible for co-ordination with different manufacturing locations for sample procurement and timely submission to Regulatory Agencies,
11) Should be responsible for preparation and evaluation of artworks for registration and product label development,
12) Should be capable of preparation and review of Drug Master Files,
13) Key role in finalization of technical documents at various stages of product development.
1) Should have leadership qualities and should be able to handle the regulatory team effectively,
2) Should have multi-tasking attributes and should have excellent communication skills to interact with Clients / Customers abroad,
3) Should be able to plan and execute the regulatory affairs activities as per marketing requirements and should be flexible to manage the priorities,
4) Should be well versed with guidelines of ICH and other regulatory agencies,
5) Should be competent with preparation, review and submission of registration dossiers in CTD and ACTD formats,
6) Should be responsible for preparation and timely submission of replies to queries raised by various Regulatory Agencies,
7) Should be responsible for technical review of quality documents on receipt from different locations before inclusion in dossiers and query responses,
8) Should have enough knowledge and experience of liaisoning with FDA for mfg. license, product permissions, CoPP, FSC, WHO-GMP and other technical documents (including notarization and/or attestation from various embassies),
9) Should be responsible for regulatory support for new product developments,
10) Should be responsible for co-ordination with different manufacturing locations for sample procurement and timely submission to Regulatory Agencies,
11) Should be responsible for preparation and evaluation of artworks for registration and product label development,
12) Should be capable of preparation and review of Drug Master Files,
13) Key role in finalization of technical documents at various stages of product development.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Keyskills: Regulatory Affairs dossierRA FDA CTDACTDBPharMPharmformulations r&d capsulesinjectablestablets
Desired Candidate Profile
Education:
Please refer to the Job description above UG - B.Pharma - Pharmacy, B.Sc - Any Specialization
PG - Post Graduation Not Required, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
PG - Post Graduation Not Required, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
PSA Chemicals and Pharmaceuticals Pvt Ltd
www.psachem.com 022-41713600
Prerana Gupta
Contact Details
Recruiter Name:Ms Prerana Bharal
Contact Company:PSA Chemicals and Pharmaceuticals Pvt Ltd
Email Address:
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